Gastroesophageal Reflux Disease Clinical Trial
— REMAINOfficial title:
Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient
| Verified date | February 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: French Data Protection Authority |
| Study type | Observational |
The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.
| Status | Completed |
| Enrollment | 275 |
| Est. completion date | November 2010 |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - At least 6 month history of GERD symptoms - Treated with unchanged optimized PPI treatment for any GERD indication during the last 4 weeks before enrollment - Remaining GERD symptoms despite optimized PPI treatment - Able to read and write in French, and able to comply with study requirements Exclusion Criteria: - Patients that have not experienced any GERD symptom improvement at all during PPI treatment - Involvement in the planning or conduct of the study - Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months - Prior surgery of the upper GI tract |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Research Site | Bandol | |
| France | Research Site | Beaumont sur Oise | |
| France | Research Site | Beausoleil | |
| France | Research Site | Behren Les Forbach | |
| France | Research Site | Berck-sur-mer | |
| France | Research Site | Bievres | |
| France | Research Site | Bordeaux | |
| France | Research Site | Bressuire | |
| France | Research Site | Brest | |
| France | Research Site | Cambrai | |
| France | Research Site | Chalon sur Saone | |
| France | Research Site | Colmar | |
| France | Research Site | Cornebarrieu | |
| France | Research Site | Creil | |
| France | Research Site | Creteil | |
| France | Research Site | Dieppe | |
| France | Research Site | Freyming Merlebach | |
| France | Research Site | Gien | |
| France | Research Site | Hagondange | |
| France | Research Site | Ivoy Le Pre | |
| France | Research Site | La Garde | |
| France | Research Site | La Rochelle | |
| France | Research Site | La Seyne sur Mer | |
| France | Research Site | Le Lavandou | |
| France | Research Site | Lyon | |
| France | Research Site | Marseille | |
| France | Research Site | Mont-de-Marsan | |
| France | Research Site | Nice | |
| France | Research Site | Paris | |
| France | Research Site | Rouen | |
| France | Research Site | Saint-mandrier | |
| France | Research Site | Sanary | |
| France | Research Site | SANARY-sur-Mer | |
| France | Research Site | Six Fours les plages | |
| France | Research Site | Six-fours | |
| France | Research Site | St Cyr sur Mer | |
| France | Research Site | St Jeannet | |
| France | Research Site | St Mande | |
| France | Research Site | Stiring Wendel | |
| France | Research Site | Toulon | |
| France | Research Site | Toulouse | |
| France | Research Site | Toussieu | |
| France | Research Site | Venerque | |
| France | Research Site | Verdun | |
| France | Research Site | Versailles | |
| France | Research Site | Witry les Reims |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | i3 Innovus |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Productivity loss; Frequency and severity of GERD symptoms; Health care resource use | Collected at enrollment visit and at 3, 6, 9 and 12 month follow-up. (Health care resource use is collected by the physician at enrollment visit and 6 and 12 month follow-up) | No | |
| Primary | Utility values; Quality of Life | Collected at enrollment visit and at 6 and 12 month follow-up. | No |
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